Safety and Preliminary Efficacy Study of SA4503 in Subjects Recovering From Ischemic Stroke

Completed

Phase 2 Results N/A

Trial Description

The purpose of this study is to evaluate the safety and tolerability of SA4503 in patients recovering from a recent stroke. Secondary, to evaluate the efficacy of SA4503 compared to placebo.

Detailed Description

Further study details as provided by M's Science Corporation:

Conditions

Interventions

  • SA4503 Drug
    Intervention Desc: A potent and selective sigma-1 receptor agonist.
  • Placebo Drug
    Intervention Desc: Oral administration
    ARM 1: Kind: Experimental
    Label: P
    Description: Placebo
  • SA4503 Low Drug
    Intervention Desc: Oral administration
    ARM 1: Kind: Experimental
    Label: A1
    Description: SA4503
  • SA4503 High Drug
    Intervention Desc: Oral administration
    ARM 1: Kind: Experimental
    Label: A2
    Description: SA4503

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Eligible patients will be randomized to receive either SA4503 or placebo orally once daily for 28 days. Study duration will be 28 days of treatment with a 28-day follow-up period.

Outcomes

Type Measure Time Frame Safety Issue
Primary Safety and tolerability will be assessed by adverse events including clinical changes and abnormal laboratories at 28 days and 56 days.
Secondary Efficacy endpoints will be NIHSS, Barthel Index, and modified Rankin Scale at 28 days and 56 days.
Primary Safety and tolerability 4 weeks Yes
Secondary NIHSS 4 weeks No

Sponsors